BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Gabriel 3 Way EnFit Valve

    K Number: K201741 · Decision Nov 5, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    49
    Applicant Total
    6
    Review Days
    133

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    Basic Information

    Device Name
    Gabriel 3 Way EnFit Valve
    K Number
    K201741
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Syncro Medical Innovations, Inc.
    Date Received
    June 25, 2020
    Decision Date
    November 5, 2020
    Product Code
    PIF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PIF Gastrointestinal Tubes With Enteral Specific Connectors

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    Other Clearances by Syncro Medical Innovations, Inc.

    K Number Device Name
    K191784 Gabriel Feeding Tube with Balloon, and EnFit Connector
    K160787 Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet
    K110005 SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
    K072787 GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111
    K021991 MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE